DUODIAGNOST

Additional Manufacturer Narrative

INT. REF: (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

Description of Event or Problem

THE CUSTOMER COMPLAINED ABOUT THE FOOTREST DETACHED AND THE PATIENT FELL. AFTER FALLING OFF THE FOOTREST, PATIENT HAD PAIN IN HER RIGHT KNEE AND HER LEFT FOREARM WHICH SLAMMED ON THE XRAY GANTRY, AFTER LOSING BALANCE. NO MEDICAL INTERVENTION OCCURRED. MINOR INJURY OCCURRED.

Additional Manufacturer Narrative

THE DUODIAGNOST SYSTEM IS A REMOTE CONTROLLED X RAY UNIT FOR CONVENTIONAL FLUOROSCOPY AND RADIOGRAPHY. THE PATIENT TABLE CAN BE CONTINUOUSLY TILTED. A DETACHABLE FOOTREST FOR THE PATIENT IS MANDATORY DURING TABLE TILTING AND SECURED BY TWO LOCKING MECHANISM. THE PHILIPS HEALTHCARE FIELD SERVICE ENGINEER HAS INVESTIGATED AT SITE. HE FOUND THAT THE FOOTREST AND LOCKING MECHANISM WAS IN A FULLY FUNCTIONAL CONDITION AND THE REASON FOR THE FOOTREST TO BE DETACHED WAS BOTH LOCKS WERE NOT SECURED AT THE TIME OF USE, WHICH WAS A MISS OR OVERSIGHT BY OPERATOR. THE INSTRUCTION FOR USE CLEARLY WARN THE OPERATOR THAT UPON THE FOOTREST MOUNTING, THE CORRECT LOCKING MUST BE CHECKED, AND DESCRIBE HOW THIS IS TO BE DONE. BASED ON THAT, A MISSING LOCKING FUNCTION IS CLEARLY RECOGNIZABLE. THE FIELD SERVICE ENGINEER EXCHANGED THE FOOTREST AS A PRECAUTION. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.